Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06921512

TCM Daoyin for Anxiety/Depression: Psychological Effects and Biological Mechanisms

Led by Shanghai University of Traditional Chinese Medicine · Updated on 2026-04-29

20

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

Sponsors

S

Shanghai University of Traditional Chinese Medicine

Lead Sponsor

S

Shanghai Mental Health Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

This 12-week single-arm clinical trial investigates the effects of Traditional Chinese Medicine (TCM) Daoyin exercise on anxiety and depression symptoms in 20 participants, followed by a 12-week observational follow-up period. The primary outcome is the change in Hamilton Anxiety Rating Scale (HAMA-14) and Hamilton Depression Rating Scale (HAMD-17) scores at 12 weeks. A secondary outcome will assess these scores at 24 weeks to evaluate sustained effects. Additional secondary outcomes include the Depression, Anxiety, and Stress Scale (DASS-21) and Pittsburgh Sleep Quality Index (PSQI) to further assess changes in mood and sleep quality at the same time points. Exploratory analyses will examine inflammatory markers, immune cell subsets, serum metabolomics, and gut microbiota at baseline, 12 weeks, and 24 weeks to identify potential biological correlates. During the follow-up period, participants will record their actual exercise engagement, allowing investigators to explore long-term associations. Findings may provide insights for future mechanistic studies on TCM's role in mental health.

CONDITIONS

Official Title

TCM Daoyin for Anxiety/Depression: Psychological Effects and Biological Mechanisms

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary symptoms of anxiety and depression, with a Hamilton Anxiety Rating Scale (HAMA-14) score between 14 and 29 and a Hamilton Depression Rating Scale (HAMD-17) score between 7 and 14
  • No prior use of psychotropic medication, or at least six months since discontinuation
  • Aged 18 to 65 years (male or female)
  • Clear consciousness and normal cognitive function, able to communicate, read, express thoughts, and perform daily activities independently
  • Willing and able to comply with blood and stool sample collection
  • Voluntary participation with signed informed consent before enrollment
Not Eligible

You will not qualify if you...

  • Diagnosed anxiety disorder or depressive disorder based on ICD-10 criteria
  • Bipolar disorder, psychotic disorders (e.g., schizophrenia), or organic mental disorders (e.g., Alzheimer's disease)
  • History of alcohol or substance use disorder within the past year, current psychiatric medication use, or high suicide risk
  • Severe or unstable medical conditions, including immune or endocrine disorders or other serious illnesses
  • Physical or psychological limitations preventing participation in the TCM Daoyin intervention
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Qigong Research Institute

Shanghai, China, 200030

Actively Recruiting

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Research Team

Y

Ying Lu, Master

CONTACT

Y

Yanyan Shang, Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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